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Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy

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ClinicalTrials.gov Identifier: NCT04904276
Recruitment Status : Recruiting
First Posted : May 27, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Brief Summary:
Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).

Condition or disease Intervention/treatment
ITP Immune Thrombocytopenia Drug: Fostamatinib

Detailed Description:
Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy (FORTE)
Actual Study Start Date : May 18, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


Group/Cohort Intervention/treatment
Initiating treatment with fostamatinib as second-line therapy Drug: Fostamatinib
Fostamatinib disodium

Treated with fostamatinib for at least 12 weeks as second-line therapy Drug: Fostamatinib
Fostamatinib disodium




Primary Outcome Measures :
  1. Fostamatinib dosing [ Time Frame: 12-month observation period ]
    Changes is fostamatinib dosing

  2. Platelet counts over time during the course of fostamatinib therapy [ Time Frame: 12-month observation period ]
    Platelet count and change from baseline in platelet count over time.

  3. Use of concomitant medications related to ITP [ Time Frame: 12-month observation period ]
    Use of concomitant medications related to ITP during the study.

  4. Use of ITP Rescue Medication [ Time Frame: 12-month observation period ]
    The number of patients with ITP rescue medication use at any time during the study.

  5. Safety of fostamatinib [ Time Frame: 12-month observation period ]
    Evaluate continued safety of fostamatinib in ITP patients through adverse events

  6. ITP-PAQ Quality of life measure [ Time Frame: 12-month observation period ]
    Use of the score from questionnaire to assess disease-specific quality of life in adults with ITP.

  7. Treatment satisfaction measure (MSQ) [ Time Frame: 12-month observation period ]
  8. SF-36 Quality of life measure [ Time Frame: 12-month observation period ]
    Scale of functional health and well-being from the patient's point of view.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This two-cohort study will enroll approximately 45 patients diagnosed with ITP. Cohort 1 will enroll approximately 30 ITP patients who will begin treatment with fostamatinib as second-line therapy. Cohort 2 will enroll approximately 15 patients who have a record of at least 12 weeks of fostamatinib treatment as second-line therapy, with the intent to continue, at time of enrollment.
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent
  2. Diagnosis of ITP in adult patients (≥ 18 years of age) with an insufficient response to steroids ± immunoglobulins and requiring a change in therapy
  3. For Cohort 1, intent to initiate fostamatinib at enrollment as change in therapy
  4. For Cohort 2, currently undergoing treatment with fostamatinib as second line therapy for at least 12 weeks, with the intent to continue, at the time of enrollment

Exclusion Criteria:

  1. Any prior ITP therapy/treatment other than steroids ± immunoglobulins (e.g. rituximab, thrombopoietin receptor agonists (TPO), splenectomy)
  2. Participation in any interventional study during the course of this study
  3. Lack of historical platelet counts, at time of fostamatinib initiation for those entering Cohort 2
  4. Pregnant and/or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04904276


Contacts
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Contact: Robert Numerof, Ph.D. 650-624-1100 rnumerof@rigel.com

Locations
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United States, Illinois
Simmons Cancer Institute at Southern Illinois University Recruiting
Springfield, Illinois, United States, 62702
Contact: Ruchika Goel, MD         
Principal Investigator: Ruchika Goel, MD         
United States, Maryland
Maryland Oncology Hematology, P.A Recruiting
Clinton, Maryland, United States, 20735
Contact: Jose Mendoza, MD    877-664-7724      
Principal Investigator: Mohit Narang, MD         
Maryland Oncology Hematology, P.A Recruiting
Columbia, Maryland, United States, 21044
Contact: Mohit Narang, MD    877-664-7724      
Principal Investigator: Mohit Narang, MD         
Maryland Oncology Hematology, P.A Recruiting
Rockville, Maryland, United States, 20850
Contact: John Wallmark, MD    877-664-7724      
Principal Investigator: Mohit Narang, MD         
Maryland Oncology Hematology, P.A Recruiting
Silver Spring, Maryland, United States, 20904
Contact: Kashif Ali, MD    877-664-7724      
Principal Investigator: Mohit Narang, MD         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: David Hughes, MD         
Principal Investigator: David Hughes, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Amber Afzal, MD         
Principal Investigator: Amber Afzal, MD         
United States, New Jersey
Regional Cancer Care Associates, LLC Recruiting
Little Silver, New Jersey, United States, 07739
Contact: Horkheimer, MD         
Principal Investigator: Ian Horkheimer, MD         
Sponsors and Collaborators
Rigel Pharmaceuticals
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Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04904276    
Other Study ID Numbers: O-FOSTA-901
First Posted: May 27, 2021    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rigel Pharmaceuticals:
Immune Thrombocytopenia
ITP
Additional relevant MeSH terms:
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Thrombocytopenia
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations